TCUPS- Tolvaptan Use in Cystinuria and Urolithiasis: A Pilot Study (NCT02538016) | Clinical Trial Compass
CompletedNot Applicable
TCUPS- Tolvaptan Use in Cystinuria and Urolithiasis: A Pilot Study
United States4 participantsStarted 2016-10
Plain-language summary
The goal of this research project is to establish that in short-term use, tolvaptan is a safe and potentially effective new therapy for cystinuria, by conducting a short-term pilot study of the safety and tolerability of this drug, and assess impact on urinary stone risk parameters, among adolescent and young adult patients with clinical cystinuria.
Who can participate
Age range
12 Years – 29 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Males and females age 12 - 29 years
* Weight ≥ 25kg (55 lbs)
* Confirmed cystinuria diagnosis
* Specific blood test levels (done within the past 6 months)
Exclusion Criteria:
* Concurrent non-renal disease that might increase risk of complications due to aquaresis
* Liver or biliary disease (chronic or acute)
* Malabsorption syndrome or other gastrointestinal condition that may interfere with response to therapy
* Non-cutaneous malignancy within last 5 years
* History of adverse reaction or allergy to Tolvaptan or other arginine vasopressin V2-receptor antagonists
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Urinary Cystine Supersaturation (mg/L) at High Dose (Day7-8)